Sequential Treatment With Trifluridine/Tipiracil and Regorafenib in Refractory Metastatic Colorectal Cancer Patients: An AGEO Prospective "Real-World Study"

被引:7
作者
Coutzac, Clelia [1 ,2 ]
Trouilloud, Isabelle [3 ]
Pascal, Artru [4 ]
Henriques, Julie [5 ]
Masson, Therese [6 ]
Doat, Solene [7 ]
Bouche, Olivier [8 ]
Coriat, Romain [9 ]
Saint, Angelique [10 ]
Moulin, Valerie [11 ]
Vernerey, Dewi [6 ]
Gallois, Claire [1 ]
De La Fouchardiere, Christelle [2 ]
Tougeron, David [12 ]
Taieb, Julien [1 ]
机构
[1] Univ Paris, Hop Europeen Georges Pompidou, Paris, France
[2] Ctr Leon Berard, Lyon, France
[3] Hop St Antoine, Paris, France
[4] Private Hosp Jean Mermoz, Lyon, France
[5] Besancon Univ Hosp, Methodol & Qual Life Oncol Unit, Besancon, France
[6] CHU Poitiers, Dept Oncol Med, Poitiers, France
[7] Univ Hosp Pitie Salpetriere, APHP, Paris, France
[8] CHU Robert Debre, Reims, France
[9] Cochin Univ Hosp, Paris, France
[10] Ctr Antoine Lacassagne, Nice, France
[11] CH La Rochelle, La Rochelle, France
[12] CHU Poitiers, Dept Hepato Gastroenterol, Poitiers, France
关键词
metastatic colorectal cancer; trifluridine/tipiracil; regorafenib; 1ST-LINE TREATMENT; BEVACIZUMAB; MULTICENTER; THERAPY; FOLFIRI;
D O I
10.1016/j.clcc.2021.12.003
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
It remains unclear which of regorafenib or trifluridine/tipiracil should be administered first in heavily pre-treated metastatic colorectal cancer patients. In this prospective multicenter real-world study, survival was similar in the regorafenib, and trifluridine-tipiracil groups. Using propensity score, PFS was significantly longer in the trifluridine-tipiracil group, whereas clinical outcomes seem to be similar regardless of the trifluridinetipiracil/regorafenib or regorafenib/trifluridine-tipiracil treatment sequence. Introduction: Regorafenib (R) and trifluridine/tipiracil (FTD/TPI) are of proven efficacy in metastatic colorectal cancer (mCRC) patient's refractory to standard therapies. However, it remains unclear which drug should be administered first. Patients and Methods: This French observational study was prospectively conducted in 11 centers between June 2017 and September 2019. All consecutive patients with chemorefractory mCRC and receiving FTD/TPI and/or R were eligible. The aim was to evaluate the efficacy and tolerability of FTD/TPI and/or R in real-world setting with adjusted analysis. Results: A total of 237 mCRC patients (25% R and 75% FTD/TPI) were enrolled. As compared to R, FTD/TPI patients were significantly older and with more metastatic sites. Median OS and PFS were respectively 6.2 and 2.4 months in the FTD/TPI and 6.6 and 2.1 months in the R group. After matching 46 paired patients according to a propensity score, a trend to a longer OS (P = .58), and a significantly longer PFS (P = .048) were observed in the FTD/TPI group. In the 24% of patients receiving the R/T or T/R sequence, median OS from first treatment was similar. Tolerability profiles were similar to published data and dose reductions were more frequent in the R group. Conclusion: Efficacy and safety results in this real-world prospective study are in line with phase III trials. In a matched population, PFS was significantly longer in the FTD/TPI group. Despite a limited number of patients, clinical outcomes seemed similar in patients treated with the T/R or R/T sequence. (C) 2021 Elsevier Inc. All rights reserved.
引用
收藏
页码:132 / 140
页数:9
相关论文
共 19 条
[1]   Survival, safety, and prognostic factors for outcome with Regorafenib in patients with metastatic colorectal cancer refractory to standard therapies: results from a multicenter study (REBACCA) nested within a compassionate use program [J].
Adenis, Antoine ;
de la Fouchardiere, Christelle ;
Paule, Bernard ;
Burtin, Pascal ;
Tougeron, David ;
Wallet, Jennifer ;
Dourthe, Louis-Marie ;
Etienne, Pierre-Luc ;
Mineur, Laurent ;
Clisant, Stephanie ;
Phelip, Jean-Marc ;
Kramar, Andrew ;
Andre, Thierry .
BMC CANCER, 2016, 16
[2]   Regorafenib dose-optimisation in patients with refractory metastatic colorectal cancer (ReDOS): a randomised, multicentre, open-label, phase 2 study [J].
Bekaii-Saab, Tanios S. ;
Ou, Fang-Shu ;
Ahn, Daniel H. ;
Boland, Patrick M. ;
Ciombor, Kristen K. ;
Heying, Erica N. ;
Dockter, Travis J. ;
Jacobs, Nisha L. ;
Pasche, Boris C. ;
Cleary, James M. ;
Meyers, Jeffrey P. ;
Desnoyers, Rodwige J. ;
McCune, Jeannines ;
Pedersen, Katrina ;
Barzi, Afsaneh ;
Chiorean, E. Gabriela ;
Sloan, Jeffrey ;
Lacouture, Mario E. ;
Lenz, Heinz-Josef ;
Grothey, Axel .
LANCET ONCOLOGY, 2019, 20 (08) :1070-1082
[3]   Rechallenge for Patients With RAS and BRAF Wild-Type Metastatic Colorectal Cancer With Acquired Resistance to First-line Cetuximab and Irinotecan A Phase 2 Single-Arm Clinical Trial [J].
Cremolini, Chiara ;
Rossini, Daniele ;
Dell'Aquila, Emanuela ;
Lonardi, Sara ;
Conca, Elena ;
Del Re, Marzia ;
Busico, Adele ;
Pietrantonio, Filippo ;
Danesi, Romano ;
Aprile, Giuseppe ;
Tamburini, Emiliano ;
Barone, Carlo ;
Masi, Gianluca ;
Pantano, Francesco ;
Pucci, Francesca ;
Corsi, Domenico C. ;
Pella, Nicoletta ;
Bergamo, Francesca ;
Rofi, Eleonora ;
Barbara, Cecilia ;
Falcone, Alfredo ;
Santini, Daniele .
JAMA ONCOLOGY, 2019, 5 (03) :343-350
[4]   Trifluridine/Tipiracil (TAS-102) in Refractory Metastatic Colorectal Cancer: A Multicenter Register in the Frame of the Italian Compassionate Use Program [J].
Cremolini, Chiara ;
Rossini, Daniele ;
Martinelli, Erika ;
Pietrantonio, Filippo ;
Lonardi, Sara ;
Noventa, Silvia ;
Tamburini, Emiliano ;
Frassineti, Giovanni Luca ;
Mosconi, Stefania ;
Nichetti, Federico ;
Murgioni, Sabina ;
Troiani, Teresa ;
Borelli, Beatrice ;
Zucchelli, Gemma ;
Dal Maso, Alessandro ;
Sforza, Vincenzo ;
Masi, Gianluca ;
Antoniotti, Carlotta ;
Di Bartolomeo, Maria ;
Miceli, Rosalba ;
Ciardiello, Fortunato ;
Falcone, Alfredo .
ONCOLOGIST, 2018, 23 (10) :1178-1187
[5]   Safety and effectiveness of regorafenib in patients with metastatic colorectal cancer in routine clinical practice in the prospective, observational CORRELATE study [J].
Ducreux, Michel ;
Petersen, Lone Norgard ;
Oehler, Leopold ;
Bergamo, Francesca ;
Metges, Jean-Philippe ;
de Groot, Jan Willem ;
Wang, Jaw-Yuan ;
Garcia Paredes, Beatriz ;
Dochy, Emmanuelle ;
Fiala-Buskies, Sabine ;
Cervantes, Andres ;
Manuel O'Connor, Juan ;
Falcone, Alfredo .
EUROPEAN JOURNAL OF CANCER, 2019, 123 :146-154
[6]   Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial [J].
Grothey, Axel ;
Van Cutsem, Eric ;
Sobrero, Alberto ;
Siena, Salvatore ;
Falcone, Alfredo ;
Ychou, Marc ;
Humblet, Yves ;
Bouche, Olivier ;
Mineur, Laurent ;
Barone, Carlo ;
Adenis, Antoine ;
Tabernero, Josep ;
Yoshino, Takayuki ;
Lenz, Heinz-Josef ;
Goldberg, Richard M. ;
Sargent, Daniel J. ;
Cihon, Frank ;
Cupit, Lisa ;
Wagner, Andrea ;
Laurent, Dirk .
LANCET, 2013, 381 (9863) :303-312
[7]   FOLFIRI plus cetuximab versus FOLFIRI plus bevacizumab as first-line treatment for patients with metastatic colorectal cancer (FIRE-3): a randomised, open-label, phase 3 trial [J].
Heinemann, Volker ;
von Weikersthal, Ludwig Fischer ;
Decker, Thomas ;
Kiani, Alexander ;
Vehling-Kaiser, Ursula ;
Al-Batran, Salah-Eddin ;
Heintges, Tobias ;
Lerchenmueller, Christian ;
Kahl, Christoph ;
Seipelt, Gernot ;
Kullmann, Frank ;
Stauch, Martina ;
Scheithauer, Werner ;
Hielscher, Joerg ;
Scholz, Michael ;
Mueller, Sebastian ;
Link, Hartmut ;
Niederle, Norbert ;
Rost, Andreas ;
Hoeffkes, Heinz-Gert ;
Moehler, Markus ;
Lindig, Reinhard U. ;
Modest, Dominik P. ;
Rossius, Lisa ;
Kirchner, Thomas ;
Jung, Andreas ;
Stintzing, Sebastian .
LANCET ONCOLOGY, 2014, 15 (10) :1065-1075
[8]   Initial Therapy with FOLFOXIRI and Bevacizumab for Metastatic Colorectal Cancer [J].
Loupakis, Fotios ;
Cremolini, Chiara ;
Masi, Gianluca ;
Lonardi, Sara ;
Zagonel, Vittorina ;
Salvatore, Lisa ;
Cortesi, Enrico ;
Tomasello, Gianluca ;
Ronzoni, Monica ;
Spadi, Rosella ;
Zaniboni, Alberto ;
Tonini, Giuseppe ;
Buonadonna, Angela ;
Amoroso, Domenico ;
Chiara, Silvana ;
Carlomagno, Chiara ;
Boni, Corrado ;
Allegrini, Giacomo ;
Boni, Luca ;
Falcone, Alfredo .
NEW ENGLAND JOURNAL OF MEDICINE, 2014, 371 (17) :1609-1618
[9]   Impact of tumour growth rate during preceding treatment on tumour response to regorafenib or trifluridine/tipiracil in refractory metastatic colorectal cancer [J].
Masuishi, Toshiki ;
Taniguchi, Hiroya ;
Kawakami, Takeshi ;
Kawamoto, Yasuyuki ;
Kadowaki, Shigenori ;
Onozawa, Yusuke ;
Muranaka, Tetsuhito ;
Tajika, Masahiro ;
Yasui, Hirofumi ;
Nakatsumi, Hiroshi ;
Yuki, Satoshi ;
Muro, Kei ;
Omae, Katsuhiro ;
Komatsu, Yoshito ;
Yamazaki, Kentaro .
ESMO OPEN, 2019, 4 (06)
[10]   Randomized Trial of TAS-102 for Refractory Metastatic Colorectal Cancer [J].
Mayer, Robert J. ;
Van Cutsem, Eric ;
Falcone, Alfredo ;
Yoshino, Takayuki ;
Garcia-Carbonero, Rocio ;
Mizunuma, Nobuyuki ;
Yamazaki, Kentaro ;
Shimada, Yasuhiro ;
Tabernero, Josep ;
Komatsu, Yoshito ;
Sobrero, Alberto ;
Boucher, Eveline ;
Peeters, Marc ;
Tran, Ben ;
Lenz, Heinz-Josef ;
Zaniboni, Alberto ;
Hochster, Howard ;
Cleary, James M. ;
Prenen, Hans ;
Benedetti, Fabio ;
Mizuguchi, Hirokazu ;
Makris, Lukas ;
Ito, Masanobu ;
Ohtsu, Atsushi .
NEW ENGLAND JOURNAL OF MEDICINE, 2015, 372 (20) :1909-1919